Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Evaluation of an interactive web-based cardiac rehabilitation programme in terms of the programme's effectiveness and acceptability in patients with angina

Acronym

OSCAR (Online Study of CArdiac Rehabilitation)

Study hypothesis

Angina is the pain associated with coronary heart disease. Often described as a heaviness, tightness or pain in the centre of the chest, which may spread to the arms, neck, and jaw, between the shoulder blades or stomach. Some people often describe a dull, persistent ache. For some people the pain or tightness is severe; for others it is not much more than a mild discomfort. Symptoms will often start intermittently on exertion, generally lasting for about 3 to 5 minutes and should be relieved by rest and glycerine trinitrate (GTN). This is known as stable angina.

Hypotheses:1. The interactive web-based cardiac rehabilitation (CR) programme is effective at favourably influencing physical activity and other risk factor profiles for patients with angina2. The interactive web-based CR programme is acceptable for patients with angina

Ethics approval

Ethics approval received from the Coventry National Research Ethics Service (NRES) on the 23rd June 2008 (ref: 08/H1210/84). However, this approval was subject to making slight adjustments to the study invitation letter and participant information sheet.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Angina

Intervention

Cardiac rehabilitation is an intervention for patients with coronary heart disease to achieve their optimal physical, emotional, social and vocational status. Typically cardiac rehabilitation programmes include exercise training, behavioural changes, education and psychological support. Past research and reviews suggest cardiac rehabilitation to be an acceptable intervention of follow up after acute myocardial infarction (AMI). The overall aim of cardiac rehabilitation is to help patients to be physically active and modify lifestyle to reduce risk factors of coronary heart disease.

Intervention:Those participants which have been randomised to the intervention group will receive the internet based cardiac rehabilitation programme for a period of 6 weeks. The researcher will provide these participants with an introductory session to the web based programme. This session will involve giving patients access to the website, describing how the website works and setting up a username and password for the participant. These participants will then be expected to follow the online cardiac rehabilitation programme for a period of 6 weeks.

Control:Participants in the control group will be required to follow treatment as usual which will consist of continuing with regular GP visits without receiving any other intervention. They will also be required to follow this for a period of 6 weeks in order to match those in the intervention group.

Both the intervention and control group will be required to complete study measures at baseline, 6 weeks and 6 months after randomisation. All participants will receive two telephone calls during the study period to check on patient progress. It is envisaged that the researcher will contact each patient in the intervention group at week 2 and week 4 of the study. Moreover, 10 - 15 participants completing the web-based intervention will be interviewed. Overall a purposeful sampling technique will be employed, however, the specific sampling technique utilised will be maximum variation sampling. This will involve purposefully picking a wide range of patients varying in demographic variables such as age, ethnic background and gender. These interviews will be recorded and transcribed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is the assessment of physical activity. Physical activity will be measured using a SenseWear Pro3 Armband. This physical activity monitor is an armband which will be used to assess participants' walking activity. Participants will be required to wear the armband on three separate occasions:1. For a period of one week, before randomisation2. For a period of one week, 6 weeks after randomisation3. For a period of one week, at a 6 month follow-up

Further, patients' attitudes and experiences of the programme will be explored using qualitative interviews. All secondary outcome measures will be taken at baseline, 6 weeks and 6 months after randomisation.

Overall trial start date

01/09/2008

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients anticipated to be aged from 45 to 70 years, either sex2. A history of stable angina3. Undergone coronary angioplasty treatment 4. Fluent in English5. No prior cardiac rehabilitation in the previous year 6. Regular access to the internet